Curricular Unit:Code:
Quality Control in Clinical Analysis1019CQAC
Year:Level:Course:Credits:
3UndergraduateClinical Analyses and Public Health6 ects
Learning Period:Language of Instruction:Total Hours:
Winter SemesterPortuguese/English78
Learning Outcomes of the Curricular Unit:
Provide students with theoretical and practical knowledge in the laboratory area with regard to Internal and External, Quality Control. Know Westgard's rules and Levey-Jennings graphics. The importance of both in laboratory quality control. Kind of errors.
Another major objective of the curricular unit is to provide the knowledge for implementing a quality management system in accordance with standards 9001/2015 and NP EN ISO/IEC 17025:2005 especially with regard to the validation of the test methods.
Provide a set of in-depth, theoretical and practical knowledge on quality management in health services.
Making known experiences and realities regarding the implementation of quality projects in a permanent connection to the world of work.
Syllabus:
Quality Control. The cross-cutting importance of this in the laboratory field.
The Westgard rules their application and importance in the laboratory field.
The Levey-Jennings charts its application and importance in the laboratory field.
ISO 9001: 2015.
1. Introduction to laboratory accreditation
1.1. Objectives
1.2. Advantages and obstacles
1.3. Quality Systems
2. ISO 9001/2015 technical requirements
2.1 Responsibilities of a quality management office
2.2 Quality manual and working instructions and procedures
2.3 SWOT Analysis
3. ISO 17025/2018 technical requirements
3.1 Accreditation of test laboratories
3.2 Accreditation of calibration laboratories
3.3 Accreditation of clinical laboratories (ISO 15189)
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
Know. Know why you do it. To be able to do. It's the 'master lines' of this chair. The student is asked to know all laboratory practices in the scope of Quality Control. And be able to contribute to the implementation of a Quality System within the framework of certification processes by ISO 9001 Standard: 2015 and NP EN ISO/IEC 17025:2017.
Teaching Methodologies (Including Evaluation):
The classes are theoretical-practical, in which a theoretical exposition of the various contents is made, allowing, however, a frequent interaction of teacher/student.
The evaluation will have a continuous characteristic. At the end of the semester there will be a moment of written evaluation in order to evaluate whether the knowledge presented is sedimented. The final score will be the average of the written test and the continuous evaluation. The minimum score for approval is 9.5 values; below which students will be referred for exam.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
Know. Know why you do it. To be able to do. It's the 'master lines' of this CU. The student is asked to know all laboratory practices in the scope of Quality Control. And be able to contribute to the implementation of a Quality System under Standard 9001: 2015. And NP EN ISO/IEC 17025:2017.
Reading:
Statistical quality Control, 7th ed.,1996. E.L.Grant.R.S. Leavenworth
Introduction to Statistical Quality Control, 3rd ed.,1996. D.C. Montgomery
Fundamentals of Quality Control and Improvement 2nd ed.Amitava Mitra. Prentice Hall
Quality Planing and AnalysisJ.M. Juran,F.Gryna
Juran´s Quality Control Handbook.J.M. Juran.
ISO 9001: 2015 e NP EN ISO/IEC 17025:2017. Norma 15189.
Procedimentos para Acreditação laboratórios-Guia 2019.
Np_ISO 9000_2015.
Apcer Guia ISO 9001_2015
Guia aplicação da 17025_2018-Acred.lab ensaio e calibração.
Guia Aplicação 15189_2017-Acreditação Laboratórios Clínicos.
Despacho 10009_2019-Aprova manual boas práticas.
Lecturer (* Responsible):
Ana Mota (amota@ufp.edu.pt)